Virtual Reality Experience in First Trimester D&C

Virtual Reality Clinical Trial

Official title:

Feasibility of an Immersive Virtual Reality Intervention for First Trimester D&C: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533036
• Other study ID #: IRB#17-001122
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Virtual reality (VR) has been used in health care settings to decrease anxiety and pain. This project is a feasibility study to evaluate whether virtual reality can be used in the setting of a first trimester pregnancy termination by D&C and whether the use of virtual reality (VR) headsets can help decrease anxiety for patients during this procedure.

Description:

The investigators will assess the practicality and qualitative experience of women using VR during first trimester surgical abortion under local anesthesia. Semi-structured interviews will be conducted to understand the patient's experience of using VR. Surveys evaluating anxiety will be administered to women before and after surgical abortion. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. A group of control patients will be enrolled; these patients will receive standard care and will be compared to the anxiety scores of the group receiving VR. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or over

• Elective surgical abortion under local anesthesia

• English speaker

Exclusion Criteria:

• No psychiatric history

• No history of motion sickness or vertigo

• No history of seizures or epilepsy

• No recent eye surgery or visual impairment

• No claustrophobia.

• No current nausea or vomiting

• Not on seizure-threshold lowering medications

Related Conditions & MeSH terms

• First Trimester Abortion
• Virtual Reality

Intervention

Device:
• applied VR headset
Virtual reality (VR) is a three-dimensional experience created by a headset fitted with a video display. The device, designed to be worn on the face, immerses the viewer in a virtual world and can create a visual distraction from the patient's present situation. We will use a commercially available VR device, comprised of a phone and headset. The phone is inserted into the headset to act as the visual display that can create three dimensional environments. The patient will then choose the virtual reality experience she prefers from the two relaxation programs available. The VR device will be introduced to the participant and fitted to her head prior to the procedure. The device is intended to be worn during the full length of the procedure until the conclusion of the D&C, however the participant may decide to stop wearing the device and choose to end the VR experience at any time.

Locations

Country	Name	City	State
United States	University of California Los Angeles Obstetrics and Gynecology Clinic	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094. — View Citation

Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801. — View Citation

Shourab NJ, Zagami SE, Golmakhani N, Mazlom SR, Nahvi A, Pabarja F, Talebi M, Rizi SM. Virtual reality and anxiety in primiparous women during episiotomy repair. Iran J Nurs Midwifery Res. 2016 Sep-Oct;21(5):521-526. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.	Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.	15 minutes
Secondary	Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).	Mean change in procedure related anxiety score as assessed by the Visual Analog Scale (VAS).; The Visual Analog Scale is a 11 point scale ranging from 0 to 10. 0 indicates the least amount of discomfort or anxiety whereas 10 represents the most amount of discomfort or anxiety.; Participants were surveyed on their level of discomfort prior to and after the procedure. The difference of these scores was taken and the average of each group is presented in as a result.	30 min